MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS; ARCTIC GEL PADS

Model Number	31700
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the arctic sun device had been alarming with flow rate issues.Nurse reconnected the pads on different places on the manifold.Patient had reached the target temperature and this was stopping therapy.User stated that if the patient needed to recommence therapy, then a different system would be used.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿adhesion gaps in film bond due to temp controller set too low or failed¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: directions for use 1.Arcticgel¿ pads are only for use with an arctic sun® temperature management system control module.See operators manual for detailed instructions on system use.2.Select the proper number, size and style pad for the patient size and clinical indication.However, the rate of temperature change and potentially the final achievable temperature is affected by pad surface area, patient size, pad placement and water temperature range.Best system performance will be achieved by using the entire pad set (4).If the entire set of pads is not used, the minimum flow rate may not be achieved.3.For patient comfort, the pads may be prewarmed using water temperature control mode (manual) prior to application.4.Place the pads on healthy, clean skin only.Remove any creams or lotions from patient¿s skin before pad application.Remove the release liner from each pad and apply to the appropriate area.The pads may be overlapped or folded adhesive-to-adhesive to achieve proper placement.The pads may be removed and reapplied if necessary.The pad surface must be contacting the skin for optimal energy transfer efficiency.Place pads to allow for full respiratory excursion.5.Attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad.6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 1.7 liters per minute, which is the minimum flow rate for a full pad kit (4).7.When finished, empty water from pads.Cold temperature increases the adhesiveness of the hydrogel.For ease of removal, leave pads on the patient for approximately 15 minutes to allow the hydrogel to warm.Slowly remove pads from the patient and discard." the device was not returned.
Event or Problem Description
It was reported that the arctic sun device had been alarming with flow rate issues.Nurse reconnected the pads on different places on the manifold.Patient had reached the target temperature and this was stopping the therapy.User stated that if the patient needed to recommence therapy, then a different system would be used.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS
• Common Device Name: ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• MDR Report Key: 11447125
• Report Number: 1018233-2021-01154
• Device Sequence Number: 11939815
• Product Code: DWJ
• UDI-Device Identifier: 00801741080005
• UDI-Public: (01)00801741080005
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 31700
• Device Catalogue Number: 31700
• Device Lot Number: NGER3634
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other